FDA.reportPublic FDA data

SENSODYNE

Manufacturer
Haleon US Holdings LLC
Effective date
2024-07-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:15:13

Label at a glance#

ProductSENSODYNE Advanced Whitening Plus
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure10 sections

Indications and uses

builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities.

Dosage and administration

adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush. brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. children under 12 years of age: Consult...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Potassium nitrate 5%

Sodium fluoride 0.25% (0.15% w/v fluoride ion)

Purposes

OTC - PURPOSE SECTION

Antihypersensitivity

Anticavity

Uses

INDICATIONS & USAGE SECTION

  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
  • aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

Stop use and ask a dentist if

OTC - STOP USE SECTION

  • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
  • pain/sensitivity still persists after 4 weeks of use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and older:
    • apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
    • brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
  • children under 12 years of age:Consult a dentist or doctor.

Other information

SPL UNCLASSIFIED SECTION

  • do not store above 25°C (77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol, hydrated silica, glycerin, pentasodium triphosphate, PEG-8, flavor, silica, xanthan gum, sodium methyl cocoyl taurate, cocamidopropyl betaine, titanium dioxide, sodium hydroxide, sodium saccharin, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-866-844-2797

ALWAYS FOLLOW THE LABEL

Additional information

SPL UNCLASSIFIED SECTION

SENSODYNE

Advanced Whitening PLUS

What are sensitive teeth?

Lots of people have sensitive teeth. When enamel is worn away (through eating everyday acidic food or

drinks) or gums recede, the dentin underneath becomes exposed. This can lead to tooth sensitivity,

for example, with cold and hot food and drinks.

What does Sensodyne do?

Sensodyne provides daily care for sensitive teeth* plus all the benefits you would expect from a daily fluoride toothpaste - strong teeth and freshness.

helps remove stains for a whiter smile, while calming the nerves deep inside the tooth for 24 hour sensitivity relief*that helps keep the pain from coming back

24/7 Sensitivity Protection*

+ Triple Action Whitening

Use Sensodyne Advanced Whitening PLUS twice daily:

• Long lasting sensitivity protection*

+ Triple action whitening

  • Removes stains
  • Polishes enamel
  • Prevents future stains

• Contains fluoride to protect against cavities

* with twice daily brushing

^ removes stains, polishes enamel,

and prevents future stains

† lower abrasivity vs Sensodyne

Advanced Whitening

CARTON RECYCLE

TUBE RECYCLE

CAP CHECK LOCALLY

†Recycling facilities for the cap may not exist in your area

Save Water

Turn off tap while brushing

Recyclable Packaging

Recyclable Carton

Recyclable Tube & Cap

Distributed by:

Haleon

Warren, NJ 07059

Trademarks owned or licensed by Haleon.

©2024 Haleon or licensor.

Pat. Info www.productpats.com

62000000209613

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4 Pack HALEON

#1 DENTIST RECOMMENDED BRAND

SENSODYNE

Advanced Whitening PLUS

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

24/7 Sensitivity Protection* + Strong & Healthy Teeth

24/7 SENSITIVITY PROTECTION + TRIPLE ACTION WHITENING

4 TUBES OF 6.5 OZ (184 g) EACH - TOTAL NET WT 26 OZ (736 g)

Sensodyne Advanced Whitening Plus 26 oz (736 g).jpg
Sensodyne Advanced Whitening Plus 26 oz (736 g).jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSN1
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCD1
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY1
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-5029-01SENSODYNEAdvanced Whitening Plus184 g in 1 TUBEPASTE1841
0135-5029-01SENSODYNEAdvanced Whitening Plus4 in 1 CARTONPASTE41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-5029SENSODYNE ADVANCED WHITENING PLUS (POTASSIUM NITRATE) PASTE [HALEON US HOLDINGS LLC]1Current NDC, 2 package rows20240713_f757ccdd-b316-4799-a34a-10edbb73da6b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-50290135-5029-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
GLYCERINPDC6A3C0OXIACT
SODIUM TRIPOLYPHOSPHATE ANHYDROUS9SW4PFD2FZIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM METHYL COCOYL TAURATEJVL98CG53GIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM HYDROXIDE55X04QC32IIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SUCRALOSE96K6UQ3ZD4IACT
POTASSIUM NITRATERU45X2JN0ZACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SENSODYNE Advanced Whitening PlusPOTASSIUM NITRATEHaleon US Holdings LLCf757ccdd-b316-4799-a34a-10edbb73da6b2024-07-12WarningsExact identifier
ndc (package): 0135-5029-01
ndc (product): 0135-5029
ndc11 (package): 00135502901
spl id: 1d136fd0-e761-deab-e063-6394a90a2452
spl set id: f757ccdd-b316-4799-a34a-10edbb73da6b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.